Certificate in EU Medical Device Directives
-- ViewingNowThe Certificate in EU Medical Device Directives is a comprehensive course designed to provide learners with a solid understanding of the legal framework and compliance requirements for medical devices in the European Union. This course covers essential topics such as the Medical Device Directive (MDD), Active Implantable Medical Device Directive (AIMDD), and In Vitro Diagnostic Medical Device Directive (IVDD).
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GBP £ 149
GBP £ 215
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โข Introduction to EU Medical Device Directives: Overview of MDD, its scope, and importance
โข Classification of Medical Devices: Understanding the classification rules and categories
โข Conformity Assessment Procedures: Overview of various conformity assessment routes
โข Technical File Requirements: Components and structure of a technical file
โข Clinical Evaluation and Investigations: Principles, methodologies, and reporting
โข Quality Management System: Implementing and maintaining a QMS according to ISO 13485
โข Vigilance and Post-Market Surveillance: Monitoring, reporting, and taking corrective action
โข Labeling and UDI Requirements: Adhering to labeling and Unique Device Identification (UDI) regulations
โข Notified Bodies and their Role: Understanding the function and selection of Notified Bodies
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